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India Issues Clarifications on New Medical Device Guidelines

On March 1, 2006, a set of guidelines on the import and manufacture of medical devices, issued by the Drug Controller General of India (DCGI), became effective in India. (Subsequently, the effective date was postponed to June 30, 2006) Ten common sterile medical devices explicitly must now be registered as drugs, by rules described in April’s PBM Asian Medical eNewsletter, Volume 6, Number 1. In June 2006, the Indian government issued a list of clarifications to the guidelines in response to questions received.

An applicant may register similar medical devices as a “family.” In this case, the entire family may be registered for a single registration fee. The products grouped together must have the same basic design, intended use, and effectiveness, but may vary in size or shape. For example, catheters made of the same materials and with the same therapeutic purpose may be registered as one family.

The “Plant Master File” required in part A of the import license application consists of the following materials: location and layout plan of the manufacturing site; overviews of the manufacturing process and quality control system; what conformity assessment system is used; production capacity of the plant; and the details of the approval or registration certificate of the plant issued by its country’s regulatory authority.

If any processing of the product takes place in India – making, altering, finishing, packaging, labeling, or breaking up – the processor must be named under “local manufacturer” in part A.

The section on “Qualitative and Quantitative Particulars of the Constituent,” in part B, requires not only the materials that make up the product, but also the standards they conform to and the system the manufacturer uses to assess their quality.

Generally, labeling that meets GHTF or ISO specifications will be accepted. However, one must check the Indian Drug and Cosmetics Rules to make sure there is no variation in one’s own case.

Although the guidelines require a guarantee that the product conforms to the manufacturer’s quality and safety standards, the government has decided that because the same guarantee is also required at the time of import, it may be left out from the import permit application form.